Article Text
Abstract
Introduction Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.
Methods and analysis The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1–7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2 <90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.
Ethics and dissemination Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.
Trial registration number ACTRN12617000147381.
- intubation
- apnoeic oxygenation
- airway management
- paediatrics
- nasal high-flow
- transnasal humidified rapid insufflation ventilatory exchange
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Footnotes
Patient consent for publication Not required.
Contributors SG, AS and SH were responsible for identifying the research question and contributing the drafting of the protocol. BGe, SE, SSG, NS, SRD, AG, KF, AC, LJS, MF, KR and TW have contributed to the development of the protocol and study design. BGa developed the health economic measures and analysis in the study. KG provided expert statistical advice and input. SG was responsible for drafting this paper, with comments and feedback from all other authors. All authors attest to having approved the final manuscript. SG and AS take responsibility for the manuscript as a whole.
Funding This research is supported by a project grant from the Emergency Medicine Foundation, a project grant from the Thrasher Research Fund and a project grant from the National Health and Medical Research Council (NHMRC). OptiFlow THRIVE™ equipment and consumables have been supplied free of charge for this study by Fisher and Paykel Healthcare, Auckland, New Zealand.
Competing interests SG, AS and SRD received travel support from Fisher and Paykel Healthcare.
Ethics approval The study protocol has been reviewed and approved by ethics committees in Australia (Children’s Health Queensland Human Research Ethics Committee, HREC/16/QRCH/81) and New Zealand (Health and Disability Ethics Committee 17/NTA/120).
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Dr Philip Sargent, Gold Coast University Hospital, Dr Christa Bell, Gold Coast University Hospital